Reinforced Balloon Catheter

ABSTRACT

A balloon catheter is described, having a reinforced, co-axial, dual lumen design. At least one of the lumens is formed of a multilayer, tubular element in which one of the layers functions, in part, to provide radial reinforcement to the tubular element.

RELATED APPLICATIONS

This application is a continuation of and claims priority to patentapplication Ser. No. 16/447,736, filed Jun. 20, 2019, entitled ImprovedReinforced Balloon Catheter, which is a continuation of and claimspriority to patent application Ser. No. 16/445,983, filed Jun. 19, 2019,entitled Improved Reinforced Balloon Catheter (now U.S. Pat. No.11,202,891 B2, issued on Dec. 21, 2021), which is a continuation of andclaims priority to patent application Ser. No. 14/949,824, filed Nov.23, 2015, entitled Improved Reinforced Balloon Catheter (now U.S. Pat.No. 10,357,638 B2, issued on Jul. 23, 2019), which claims benefit of andpriority to U.S. Provisional Application Ser. No. 62/083,093 filed Nov.21, 2014 entitled Improved Reinforced Balloon Catheter, all of which arehereby incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

Balloon catheters are increasingly being employed to conductneurological procedures in patients. However, the design parameters forballoon catheters intended for use in neurological procedures aresignificantly different than the design parameters for balloon cathetersused in non-neurological procedures such as cardiological procedures.For example, the width of the circulatory system within the neuroanatomyis significantly smaller and more tortuous than the circulatory systemin other parts of the body. In order to access the smaller and moretortuous regions of the neuroanatomy, it is necessary to minimize theouter diameter of the balloon catheter while simultaneously maintainingthe pushability and trackability of the catheter.

In order to minimize the outer diameter, current balloon cathetersintended for neurological procedures employ a non-reinforced, singlelumen, over-the-wire design. Accordingly, these balloon catheters areprone to several problems. First, the non-reinforced lumen issusceptible to ovalizing and/or kinking which, in turn, hindersadvancement of the catheter over the guidewire, as well as deflation ofthe balloon. Second, the single lumen is in communication with thearterial blood flow. As the guidewire and balloon catheter aremanipulated through the circulatory system, blood is withdrawn into thesingle lumen of the balloon catheter. Blood may thereby enter theballoon during inflation and cause (1) poor imaging of the balloon, forexample, poor fluoroscopic imaging; (2) poor passage of the balloonthrough the circulatory system due to the premature inflation of theballoon; and (3) poor deflation of the balloon due to blood coagulationin the balloon inflation/deflation port. An additional disadvantage ofsingle lumen balloon catheters is that the interference fit of theguidewire and inflation seal of the balloon may result in removal orpeeling of the hydrophilic coating of the guidewire.

In order to minimize the outer diameter, current balloon cathetersintended for neurological procedures are also typically designed to workwith only a narrow gauge guidewire that is supplied by a manufactureralong with the balloon catheter. The current balloon catheters employguidewires having diameters in the range of 0.010 to 0.012 inches. Theserelatively narrow guidewires are soft and, therefore, are very difficultto maneuver through the small, tortuous neuroanatomy.

What is needed in the field is a balloon catheter that is operable touse with larger gauge guidewires; resists ovalizing and kinking of theinflation and guidewire lumen(s); and deploys with improved pushabilityand trackability.

SUMMARY OF THE INVENTION

In one embodiment, the present invention includes a balloon catheterthat is operable to use with large gauge guidewires, resists ovalizingand kinking of the inflation and guidewire lumen(s), and deploys withimproved pushability and trackability.

The present invention according to another embodiment provides a ballooncatheter that employs a reinforced, co-axial, duel lumen design. Incertain embodiments, the lumen are formed of a multilayer, tubularelement in which one of the layers functions, in part, to provide radialreinforcement to the tubular element.

In another embodiment of the present invention, the distal portion of anouter lumen is locked or fixed to a portion of an inner lumen. Aproximal portion of a balloon is attached to a distal portion of theouter lumen and a distal portion of the balloon is attached to a distalportion of the inner lumen.

In another embodiment, a fluid flow passage is provided between theouter lumen and an interior volume of the balloon, and a passageexclusive to gas or air is formed from the interior volume of theballoon longitudinally through a distal portion of the balloon catheter.

In certain other embodiments, de-airing channels or features areemployed between an exterior surface of the inner lumen and an interiorsurface of the balloon in order to facilitate purging of gas from theinflation passageway of the balloon catheter.

In another embodiment, a tapered inflation lumen is utilized. In anotherembodiment a tapered guidewire lumen is utilized. In another embodiment,both the inflation lumen and guidewire lumen are tapered. The taper canbe continuous throughout the lumen(s), or localized within a particularregion of the lumen(s).

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is an elevation view of a balloon catheter according to oneembodiment of the present invention.

FIG. 2 is a partial elevation view of a balloon catheter according toone embodiment of the present invention.

FIG. 3 is a cross-sectional view taken along line A-A of FIG. 1 of aballoon catheter according to one embodiment of the present invention.

FIG. 4A is a partial elevation view of an outer assembly of a ballooncatheter according to one embodiment of the present invention.

FIG. 4B is a cross-sectional view taken along line C-C of FIG. 4A of anouter assembly of a balloon catheter according to one embodiment of thepresent invention.

FIG. 5A is a partial elevation view of an inner assembly of a ballooncatheter according to one embodiment of the present invention.

FIG. 5B is a cross-sectional view taken along line D-D of FIG. 5A of aninner assembly of a balloon catheter according to one embodiment of thepresent invention.

FIG. 5C is a cross-sectional view taken along line E-E of FIG. 5A of aninner assembly of a balloon catheter according to one embodiment of thepresent invention.

FIG. 6 is an expanded view of region 13 indicated in FIG. 1 of a ballooncatheter according to one embodiment of the present invention.

FIG. 7 is a cross-sectional view taken along line B-B of FIG. 2 of aninner assembly of a balloon catheter according to one embodiment of thepresent invention.

FIG. 8 is a cross-sectional view taken along line D-D of FIG. 5A of aninner assembly of a balloon catheter according to one embodiment of thepresent invention.

FIG. 9 is a cross-sectional view taken along line B-B of FIG. 2 of aninner assembly of a balloon catheter according to one embodiment of thepresent invention.

FIGS. 10-11 show a longitudinal view of tapered outer lumen of a ballooncatheter according to one embodiment of the present invention.

FIGS. 12-18 show various embodiments of an air purging system that canbe used in a balloon catheter.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The balloon catheter of the present invention addresses many of theshortcomings of the current balloon catheters intended for use inneurological procedures. Broadly speaking, the balloon catheter of thepresent invention employs a reinforced, co-axial, duel lumen design. Theinner most lumen is operable to serve, among other functions, as aguidewire lumen for over-the-wire type procedures. The outer lumen isoperable to serve as an inflation lumen for one or more balloonspositioned along the length of the balloon catheter. Each lumen isformed by a multilayer, tubular element in which one of the layers, forexample a middle layer in a three-layer embodiment, functions in part toprovide radial reinforcement to the tubular element. Accordingly, theballoon catheter of the present invention is operable with larger gaugeguidewires; resists ovalizing and kinking of the inflation and guidewirelumens; and deploys with improved pushability and trackability overcurrent balloon catheters intended for use in neurological procedures.

With reference to FIGS. 1-3 and 6 , a balloon catheter 10 according toone embodiment of the present invention comprises a hub 12, a balloon18, and an outer assembly 14 having a lumen 20 through which an innerassembly 16 is co-axially positioned. As best shown in FIG. 6 , anexpanded view of region 13 indicated in FIG. 1 , a proximal portion 36of the outer assembly 14 is associated with an inflation lumen 32 of thehub 12. A proximal portion 38 of the inner assembly 16 extendsproximally from the lumen 20 of the outer assembly 14 and is associatedwith a guidewire port 34 of the hub 12. At an opposite end of thecatheter, a proximal portion 24 of the balloon 18 is associated with adistal portion 26 of the outer assembly 14, and a distal portion 28 ofthe balloon 18 is associated with a distal portion 30 of the innerassembly 16. Alternatively stated, the opposite ends of the balloon 18span between the distal portion 26 of the outer assembly 14 and thedistal portion 30 of the inner assembly 16.

As shown in FIGS. 4A and 4B, the outer assembly 14 is a tubularstructure having a multilayer wall; an inner layer 40, middle layer 42,and outer layer 44. The inner layer 40 of the outer assembly 14 isformed of a longitudinally continuous or segmented tubular element. Inembodiments in which the inner layer 40 of the outer assembly 14 isformed of longitudinally segmented tubular elements the individualsegments may be fabricated from the same or different materials and maybe attached to one another by welding, fusing, adhering, melting, orother polymerizing or non-polymerizing methods. The inner layer 40 ofthe outer assembly 14 is fabricated from one or more different polymericmaterials, or, alternatively, the inner layer 40 of the outer assembly14 is formed of a single etched polytetrafluoroethylene, PTFE, tube.While a variety of materials are contemplated for use in fabricating theinner layer 40 of the outer assembly 14, of particular importance is thefeature that the material from which the inner layer 40 is formed has ahigher melting temperature than the temperature employed to fuse orotherwise attach the outer layer 44 to the inner layer 40 and middlelayer 42 of the outer assembly 14.

In one embodiment of the present invention, the middle layer 42 of theouter assembly 14 comprises a wire 46 wound in a coil-like form aroundthe outer surface 48 of the inner layer 40 of the outer assembly 14. Thewire 46 may be wound in a single layer from one end of the inner layer40 to the other end to form a coil-like structure or, alternatively, maybe wound repeatedly from one end of the inner layer 40 to the other endto form a multilayer coil-like form, as shown in FIG. 4A. In embodimentsemploying the middle layer 42 having a multilayered coil-like form, thedifferent windings may be formed from a single or multiple independentwires 46. The wire 46 may have a circular, rectangular, triangular, orflattened ribbon-like cross-sectional shape, or combinations thereof.The wire 46 is fabricated from a variety of polymeric and/or metallicmaterials, for example stainless steel. The wire 72 has a diameter thatis variable or consistent along the length of the wire 72. For example,the wire 72 may have a diameter of approximately 0.001 inches. It isalso contemplated that the middle layer 42 be formed of a mesh, a braid,and/or an interweaving of one of more wires 46.

The pitch of the winding of the wire 46 may be either consistent orvaried along the length of the inner layer 40. For example, a firstproximal segment of the winding may have a pitch of approximately 0.003inches, a second more distal segment may have a pitch of approximately0.0035 inches, a third more distal segment may have a pitch ofapproximately 0.004 inches, a fourth more distal segment may have apitch of approximately 0.0045 inches, a fifth more distal segment mayhave a pitch of approximately 0.005 inches, and a sixth more distalsegment may have a pitch of approximately 0.001 inches. In embodimentsemploying the middle layer 42 having a multilayered coil-like form theouter most winding may, for example, have a pitch of approximately 0.100inches.

In one embodiment of the present invention, the outer layer 44 of theouter assembly 14 comprises a longitudinally continuous or segmentedtubular element. The outer layer 44 of the outer assembly 14 is formedof longitudinally segmented, non-heat shrinkable, tubular elements. Theindividual segments may be fabricated from the same or differentmaterials and may be attached to one another by welding, fusing,adhering, melting, or other polymerizing or non-polymerizing methods, orcombinations thereof.

In one embodiment, the outer layer 44 of the outer assembly 14 isfabricated from multiple different polymeric tubular segments. Forexample, a proximal segment 50 of the outer layer 44 of the outerassembly 14 may be formed of a tubular polyamide such as Girlamid L25.The proximal segment 50 has a length 51, of, for example, approximately110 centimeters. A second more distal segment 52 may be formed of atubular poly ether block amide such as Pebax 72D. The second more distalsegment 52 has a length 53, of, for example, approximately 10centimeters. A third more distal segment 54 may be formed of a tubularpoly ether block amide such as Pebax 63D. The third more distal segment54 has a length 55, of, for example, approximately 5 centimeters. Aforth more distal segment 56 may be formed of a tubular poly ether blockamide such as Pebax 55D. The forth more distal segment 56 has a length57, of, for example, approximately 20 centimeters. A fifth more distalsegment 58 may be formed of a tubular poly ether block amide such asPebax 45D. The fifth more distal segment 58 has a length 59, of, forexample, approximately 10 millimeters. A sixth more distal segment 60may be formed of a polyolefin such a Plexar. The sixth more distalsegment 60 has a length 61, of, for example, approximately 2millimeters. A distal most segment 62 may be formed of a polyolefin suchan Engage 8003. The distal most segment 62 has a length 63 of, forexample, approximately 13 centimeters.

The outer assembly 14 may be fabricated by first wrapping the wire 46around the inner layer 40 thereby forming the middle layer 44. Thetubular segment or segments of the outer layer 44 are then slid over themiddle layer 42. A heat shrinkable tube of, for example, fluorinatedethylene propylene, FEP, is then slid over the outer layer 44. The FEPis heated so as to deliver heat to the outer layer 44, and the outerlayer 44 then softens to encapsulate the wire 46. The FEP tube is thenremoved from the outer layer 44.

In one embodiment of the present invention, the outer diameter of theouter layer 44 of the outer assembly 14 is in the range of 0.03 to 0.040inches. The lumen 20 of the outer assembly 14 may have a diameterbetween 0.020 to 0.029 inches. In one embodiment, the lumen 20 of theouter assembly 14 may have a diameter of approximately 0.0285 inches.

As shown in FIGS. 5A and 5B, the inner assembly 16 is a tubularstructure having a multilayer wall formed of an inner layer 64, middlelayer 66, and outer layer 68. The inner layer 64 of the inner assembly16 is formed of a longitudinally continuous or segmented tubularelements. In embodiments in which the inner layer 64 of the innerassembly 16 is formed of longitudinally segmented tubular elements, theindividual segments may be fabricated from the same or differentmaterials and may be attached to one another by welding, fusing,adhering, melting, or other polymerizing or non-polymerizing methods, orcombinations thereof. The inner layer 64 of the inner assembly 16 isfabricated from one or more different polymeric materials, or,alternatively, the inner layer 64 of the outer assembly 14 is formed ofa single, non-segmented, etched polytetrafluoroethylene, PTFE, tube.While a variety of materials are contemplated for use in fabricating theinner layer 64 of the inner assembly 16, it is important to employ amaterial that has a higher melting temperature than the temperatureemployed to fuse or otherwise attach the outer layer 68 to the innerlayer 64 and middle layer 66 of the inner assembly 16. It is alsodesirable to employ a material that has a relatively low co-efficient offriction.

In one embodiment of the present invention, the middle layer 66 of theinner assembly 16 comprises a wire 70 wound in a coil-like form aroundthe outer surface 72 of the inner layer 64 of the inner assembly 16. Thewire 72 may be wound in a single layer from one end of the inner layer64 to the other or, alternatively, may be wound repeatedly from one endof the inner layer 64 to the other to form a multilayer coil-like form,as shown in FIG. 4A regarding wire 46 of the outer assembly 14. Inembodiments employing the middle layer 66 having a multilayeredcoil-like form, the different coils may be formed from a single ormultiple independent wires 72. The wire 72 may have a circular,rectangular, triangular, flattened, ribbon-like cross-sectional shape,or a combination thereof. The wire 72 may be fabricated from a varietyof metallic and/or polymeric materials, for example stainless steel. Thewire 72 may have a diameter that is variable or consistent along thelength of the wire 72. For example, the wire 72 may have a diameter ofapproximately 0.001 inches. It is also contemplated that the middlelayer 42 may be formed of a mesh or interweaving of one of more wires46.

The pitch of the winding of the wire 72 may be either consistent orvaried along the length of the inner layer 64 of the inner assembly 16.For example, a first proximal segment of the wire 72 winding may have apitch of approximately 0.003 inches, a second more distal segment mayhave a pitch of approximately 0.003 inches, and a third most distalsegment may have a pitch of approximately 0.001 inches.

As shown in FIGS. 2 and 5A, in one embodiment of the present invention,one or more marker bands 82A, 82B, and 82C are placed, for example, overthe wire 70 forming the middle layer 66 of the inner assembly 16. Themarker bands 82A, 82B, and 82C comprise a radiopaque material such asgold, platinum, or silver, and are used for determining the location ofthe balloon catheter 10 within a patient. In certain embodiments of thepresent invention the maker band 82A may be placed a distance L3proximate to a distal end 86 of the inner assembly 16. For example, thedistance L3 may be 5 millimeters. In one embodiment, instead of markerbands, marker coils may be used. In one embodiment, two sets of markercoils are used where one coil overlaps another to augment theradiopacity of the marker elements.

The marker bands 82B and 82C may be positioned further proximal of themarker band 82A so as to indicate or mark the proximal portion 24 andthe distal portion 28 of the balloon 18. It will be understood that theexact placement of the marker bands 82B and 82C relative to the distalend 86 of the inner assembly 16 will depend on the dimensions of theballoon 18 employed in the balloon catheter 10.

For example, in an embodiment employing a balloon 18 of 10 millimetersin length, a proximal end 84 of the marker band 82C is a distance L1from the distal end 86 of the inner assembly 16. For example, thedistance L1 may be approximately 19.5 millimeters. Opposite ends of themarker bands 82B and 82C are a distance L2 from one another. Forexample, the distance L2 may be 10 millimeters. In an embodimentemploying a balloon 18 of 20 millimeters in length, the distance L1 is,for example, approximately 29.5 millimeters, and the distance L2 is, forexample, 20 millimeters. In another embodiment, the marker band 82C maybe placed directly underneath inflation plug 88.

In one embodiment of the present invention, the outer layer 68 of theinner assembly 16 comprises a longitudinally continuous or segmentedtubular element. Preferably the outer layer 68 of the inner assembly 16is formed of series of longitudinally segmented, non-heat shrinkable,tubular elements. The individual segments are fabricated from the sameor different materials and may be attached to one another by welding,fusing, adhering, melting, or other polymerizing or non-polymerizingmethods. Preferably, the outer layer 68 of the inner assembly 16 isfabricated from multiple different polymeric tubular segments. Forexample, a proximal segment 74 of the outer layer 68 of the innerassembly 16 may be formed of a tubular poly ether block amide such asPebax 63D. The proximal segment 74 has a length 75 of, for example,approximately 150 centimeters. A second more distal segment 76 may beformed of a tubular poly ether block amide such as Pebax 45D. The secondmore distal segment 76 has a length 77 of, for example, approximately 10centimeters. A third more distal segment 78 may be formed of apolyolefin such as Plexar 3080. The third more distal segment 78 has alength 79 of, for example, approximately 2 millimeters. A distal mostsegment 80 may be formed of a polyolefin such as Engage 8003, and have alength 81 of, for example, approximately 5 centimeters.

The inner assembly 16 may be fabricated by first wrapping the wire 70around the inner layer 64 thereby forming the middle layer 66. Next, themarker bands 82A, 82B, and 82C are placed over or within the middlelayer 66, and the tubular segment or segments of the outer layer 68 arethen slid over the marker bands 82A, 82B, and 82C and the middle layer66. A heat shrinkable tube of, for example, fluorinated ethylenepropylene, FEP, is then slid over the outer layer 68. The FEP is heatedso as to deliver heat to the outer layer 68, thereby softening the outerlayer 68 so as to encapsulate the wire 70 forming the middle layer 66.The FEP tube is then removed from the outer layer 68.

In one embodiment of the present invention, the wire 70 forming themiddle layer 66 of the inner assembly 16 may terminate proximal of thedistal end 86 of the outer assembly 16. A tubular element 100 may beemployed in all or a portion of the length between the distal end 86 andthe point at which the wire 70 terminates. The tubular element 100 may,for example, be formed of a crosslinked polyolefin tube having a lengthof approximately 5 millimeters.

In one embodiment of the present invention, the outer diameter of theouter layer 68 of the inner assembly 16 is in the range of 0.015 to0.025 inches, and more preferably in the range of 0.020 to 0.0225inches.

As shown in FIGS. 2, 5A, and 5C, in one embodiment of the presentinvention, the inner assembly 16 may further comprise an inflation plug88. The inflation plug 88 is formed of a tubular segment of materialhaving a wall of either uniform or asymmetric thickness. In someembodiments, the inflation plug may have a durometer ranging between 18Ato 55D. The inflation plug 88 may, for example be formed of a poly etherblock amide such as Pebax 55D. The inflation plug may, for example, beapproximately 5 millimeters in length and a distal end 90 of theinflation plug 88 may, for example, be positioned approximately 4millimeters from the proximal end 84 of the marker band 82C. An outerdimension or diameter of the inflation plug 88 is large enough so thatthe inflation plug 88 may not completely pass into the lumen 20 of theouter assembly without significant force. The inflation plug 88 may beformed on the inner assembly 16 as described above regarding theformation of the outer layer 68 of the inner assembly 16.

As shown in FIG. 5C, the inflation plug 88 may comprise one or morepassages or channels 92 formed longitudinally along the length of theinflation plug. The channel 92 may be formed by placing a mandrellongitudinally along the outside surface of the inflation plug 88 priorto sliding the heat shrinkable tube of, for example, FEP over theinflation plug 88. When the FEP is heated so as to deliver heat to theinflation plug 88, the mandrel melts into the inflation tube thereby thechannel 92 within the inflation plug 88. The FEP tube is then removedfrom the inflation plug 88.

The inflation plug 88 functions, in part, to longitudinally lock theinner assembly 16 to the outer assembly 14 so as to prevent changes inthe length of the distal extension of the distal portion 30 of the innerassembly 16 relative to a distal end 98 of the outer assembly 14 due tothe inflation and orientation of the balloon 18 during a procedure. Thepassage or channel 92 formed in the plug 88 allows for fluidcommunication between the lumen 20 of the outer assembly and an interiorvolume of the balloon 18.

As shown in FIGS. 3, 5B, 5C, and 7 , the inner assembly 16 comprises aninner lumen 22. The lumen functions as a guidewire lumen forover-the-wire procedures. The lumen 22 of the inner assembly 16 may havea diameter of at least approximately 0.0165 inches. Accordingly, theballoon catheter 10 of the present invention may be used with guidewireshaving a larger diameter than the guidewires supplied with currentballoon catheters intended for use in neurological procedures. Forexample the present balloon catheter 10 may be used with a guidewirehaving a diameter of 0.014 inches. This feature allows a physician tomore easily access a neuroanatomical target, such as an aneurysm, sincethe relatively larger guidewire provides more support for the ballooncatheter 10 over which to track.

Additionally, the guidewire may be removed from the lumen 22 afterplacement of the balloon catheter within a patient and the lumen 22 mayserve as a functional lumen for passage of additional medical devices orsubstances to the target location within the patient.

It will be understood that it is generally beneficial for the outerassembly 14 and the inner assembly 16 to be more flexible at theirdistal portions than their proximal portions. Furthermore, it iscontemplated that the distal portions of the outer assembly 14 and/orthe inner assembly 16 may be pre-shaped or operable to be shaped by aphysician prior to initiating a procedure using, for example, steamshaping techniques.

As shown in FIGS. 1 and 6 , the proximal portion 36 of the outerassembly 14 terminates distally of the proximal portion 38 of the innerassembly 16. Accordingly, the lumen 20 of the outer assembly is incommunication with the inflation port 32. FIGS. 1 and 6 also show thatthe proximal portion 38 of the inner assembly 16 extends proximallybeyond the proximal portion 36 of the outer assembly 14 and isassociated with the guidewire port 34 of the hub 12. Accordingly, thelumen 22 of the inner assembly and the guidewire port 34 of the hub 12together form a substantially continuous lumen through which a guidewireor other medical device may pass. The outer assembly 14 and the innerassembly 16 may be attached to the hub 12 by various methods, includingwelding, fusing, adhering, melting, or other polymerizing ornon-polymerizing method, or combinations thereof. It is noted that thisconfiguration of the hub 12 and association of the hub 12 with the outerassembly 14 and the inner assembly 16 advantageously provides for theisolation of the lumen 22 of the inner assembly 16 from the lumen 20 ofthe outer assembly 14. The isolation of these lumens and theirfunctionality serves, in part, to address many of the shortcomingsdescribed above regarding the current single lumen balloon cathetersintended for neurological procedures.

As shown in FIGS. 1 and 2 , the proximal portion 24 of the balloon 18 isassociated with the distal portion 26 of the outer assembly 14, and thedistal portion 28 of the balloon 18 is associated with the distalportion 30 of the inner assembly 16. The balloon 18 may be attached tothe distal portion 26 of the outer assembly 14 and the distal portion 30of the inner assembly 16 by various methods including welding, fusing,adhering, melting, or other polymerizing or non-polymerizing methods andcombinations thereof. In certain embodiments, the distal portion of theballoon 18 covers and extends to the distal end 86 of the inner assembly16. The balloon 18 may, for example, be formed of Polyblend 45A or otherpolymeric elastomeric material. The balloon 18 may have an outerdiameter of up to approximately 15 millimeters and a length in the rangeof 5 to 50 millimeters and, preferably a length in the range of 10 to 20millimeters.

As shown in FIG. 7 , in one embodiment of the present invention, one ormore air purge ports 94 are employed at the interface of the distalportion 30 of the inner assembly 16 and the distal portion 28 of theballoon 18. The air purge ports 94 are formed by placing one of moremandrels having diameters in the range of 0.0005 to 0.030 inches on theouter surface of the outer layer 68 of the inner assembly 16. Aninterior surface 96 of the balloon 18 is then attached over the mandrelsto the outer layer 68 of the inner assembly 16. After the balloon 18 isattached to the distal portion 30 of the inner assembly 16 the mandrelsare removed. Accordingly, flow paths large enough for the passage of gasand small enough to seal against the passage of liquids are formed.

The air purge ports 94 function to facilitate removal of air from thelumen 20 and balloon 18 prior to initiating a medical procedure. Withcurrent co-axial balloon catheters, it is very difficult to remove allof the air from the inflation/deflation lumen prior to initiating amedical procedure. Physicians typically must remove the air from aballoon catheter through several minutes of aspiration or suctionthrough the inflation/deflation lumen. Air that is not removed will showin images taken during the procedure and may obscure details that thephysician may otherwise need to observe in order to perform theprocedure.

In contrast, the air purge ports 94 of the present invention allow auser to more effectively and more efficiently remove air from the lumen20, the inflation/deflation lumen. In practice, prior to initiating theprocedure, a physician positions the distal end of the balloon catheter10 higher than the proximal end and then inject a balloon inflationmedium, such as contrast medium or saline, through the inflation port 32and associated lumen 20. As the inflation medium fills the lumen 20, airis forced out the air purge ports 94 until no air remains within thelumen 20 or balloon 18. The physician may repeat the process as neededto ensure that all air is removed from the lumen 20 of the outerassembly 14 and balloon 18.

In another embodiment of the present invention, as shown in FIGS. 8 and9 , the above described functionality of the inflation ports 32 isenhanced by employing one or more de-airing channels 102. The de-airingchannel 102 is formed in the outer layer 68 of the inner assembly 16. Ata minimum, the de-airing channel 102 initiates longitudinallyapproximate the distal end 90 of the inflation plug 88 and continuesuninterruptedly to approximately a proximate end of the air purge port94. The length of the de-airing channel 102 may extend to or overlapwith the distal end 90 of the inflation plug 88 and/or the proximate endof the air purge port 94. The de-airing channel 102 may be eitherradially aligned or radially off set with the channel 92 of theinflation plug 88 and/or the air purge port 94 relative to an axisthrough the lumen 22 of the inner assembly 16.

The de-airing channel 102 is formed by placing one of more mandrelshaving diameters in the range of 0.001 to 0.030 inches between the outerlayer 68 of the inner assembly 16 and the heat shrinkable tube and thenheating the heat shrinkable tube as described above. In certainembodiments, the de-airing channel 102 is radially aligned with the airpurge port 94 and/or with the channel 92 formed in the inflation plug88. For example, FIG. 9 shows an embodiment in which the de-airingchannel 102 is radially aligned with the air purge port 94. Thede-airing channel 102 and the air purge port 94 each form a portion of aunified channel. In embodiments in which the de-airing channel 102 isradially aligned with the air purge port 94 and/or with the channel 92formed in the inflation plug 88, the de-airing channel 102 may extendlongitudinally the length of the air purge port 94 and/or may extendlongitudinally into or proximately beyond the channel 92 formed in theinflation plug 88.

The de-airing channel 102 helps ensure that a fluid and air flow path ismaintained unobstructed between the exterior surface of the innerassembly 16 and the interior surface 96 of the balloon 18. Because theballoon 18 may be closely form fitted over the inner assembly 16 whenthe balloon is not inflated, absent a de-airing channel 102, it may notalways be possible to purge air from lumen 20 of the outer assembly 14without inflating the balloon 18. Hence, the de-airing channel 102provides a recess or unobstructed channel on the exterior surface of theinner assembly 16 that allows the passage of air and fluid between thedeflated balloon and the exterior surface of the inner assembly 16.Hence, air may be purged from the balloon catheter 10 without inflatingof the balloon 18.

It is also contemplated that the de-airing channel 102 may take the formof one or more spiral channels or grooves, spiral ridges, and/orlongitudinal ridges on the exterior surface of the inner assembly 16.The de-airing channel 102 may also take the form of one or more smalltubular elements bonded to the exterior surface of the inner assembly16.

Different additional embodiments of the purge ports are alsocontemplated in connection with any of the previously describedembodiments of this specification. It should be noted that while theterm purge port is used, this term may include an elongated passagethrough the device, as well as a port exiting the device. In thefollowing embodiments shown in FIGS. 12-18 , the purge port is locatedat the distal end of the balloon 18, and connects a distal portion ofthe balloon 18 to the distal tip 30 of the catheter 10. Thus, all thepurging is performed at the distal portion of the balloon catheter 18.The inflation lumen remains located proximal to the balloon 18, and thusthe balloon 18 is inflated from the proximal end while all the purgingis performed at the distal section of the balloon 18. As described inthe following embodiments, the purge port 94 remains open initially topurge air from the balloon 18 during a first, preparation stage; andthen the purge port is sealed in a second, operational state to preventthe balloon from leaking when the balloon is used in an interventionalprocedure.

One embodiment includes a swellable material along with the previouslydescribed purge port arrangement. It may be desirable to selectivelyallow the purge port to remain open to purge air, but to close uponexposure to liquid (such as saline or contrast agent, used to flush theair from the purge port) to keep the balloon inflated over time. In oneexample, the user flushes the system with contrast agent to expel airfrom the purge port to prep the balloon for use. Contrast agent is alsoused to inflate the balloon. Thus, once the air is purged from the purgeport, the purge port closes to prevent contrast agent from laterescaping once additional contrast agent is later introduced to inflatethe balloon (i.e. once the balloon is in the body and the interventionalprocedure is undertaken).

One such embodiment that addresses this issue includes a swellablematerial either on the purge port itself or adjacent to the purge port.A hydrophilic material swells upon exposure to liquid (i.e. saline orcontrast agent) and thus close the purge port lumen once the relevantsection of the purge port was exposed to the liquid. Thus, the purgeport stays open as air is expelled through the port, but once the distalpurge port contacts the liquid (meaning the air is almost completelyflushed from the system), the purge port will start to swell andeventually contract, blocking the liquid from being expelled.

The swellable material may be located adjacent the purge port or mayphysically comprise a distal section of the purge port. FIG. 12 showssuch a system, utilizing a swellable material adjacent the purge port.Specifically, FIG. 12 illustrates a cross section near the distal end ofthe balloon 18, where the purge port 94 spans a distal portion of theballoon 18. The swellable layer 110 is located under purge port 94, inaddition to optional additional liner layers 112, 114, 116, which can belocated between guidewire lumen 16 and swellable layer 110. Alternately,the swellable material can be used with any of the prior embodiments.

As previously discussed, alternative configurations may position theswellable material on a distal section of the purge port 94, therebyallowing the purge port to contract upon exposure to liquid instead ofhaving an adjacent surface compressing the purge port. Alternatively,the entirely of the purge port 94 itself may utilize the swellablematerial. Any hydrophilic material can be used in the swellable layer,such as rubber or hydrogel.

In another embodiment, the purge port 94 is collapsible. In oneembodiment, the purge port 94 remains in an otherwise open configurationbut collapses in response to a stimulus (such as aspiration or avacuum). The user prepares the balloon 18 by introducing an agent (e.g.,saline or contrast agent) to clear the air from the balloon 18. Next,the user introduces a vacuum or aspiration source which causes the purgeport 94 to collapse and thereby shut. Later in the procedure, when theballoon 18 is positioned in the body, the purge port 94 will remainsealed and the inflation media (i.e. contrast agent) will not escape,preventing the balloon 18 from leaking over time.

A soft, tacky, and collapsible material can be used to create the purgeport 94 to enable the port to easily collapse. An elliptical crosssectional shape may also be desirable for such a system so that theminor axis of the ellipse requires only minor movement to collapsecompletely, although a more rounded shape may also be used where thepurge port walls are composed of a relatively weak polymer material thatallows easy collapse. Additional cross sectional shapes, such as a “D”or “C” shape, are also possible. In these example shapes, the flat sideof the “D” shape or the open portion of the “C” shape can be orientedsuch that they are either facing a direction toward the guidewire lumen16 or facing away from the guidewire lumen 16 (i.e., facing “downward”or “upward” in the example cross section of FIG. 12 )

In one example, the entire length of the purge port 94 is collapsible.In another example, only a section of the purge port 94 is collapsible.This collapsible section may be accomplished by a variety of methods,such as creating a weakened wall region in a section of the length,allowing that section to easily constrict. FIGS. 13-14 show acollapsible purge port in which the purge port has a first openconfiguration 94 a when the purge port is open to purge the system, andthe purge port subsequently adopts a second closed configuration 94 bonce vacuum or aspiration is used to close the purge port 94.

In another embodiment, the purge port 94 includes a restricting memberpositioned at or past the proximal end of the purge port 94 to blockflow at the proximal part of the purge port 94 once the balloon 18 hasbeen collapsed over the purge port, thereby preventing over-aspiration.This restricting member may be a wall region having an increasedthickness and located at the proximal end of the purge port 94 to blockthe purge port lumen. This restricting member can also be described as abump or protruding region.

In operation, the user aspirates to deflate the balloon, and sinceover-aspiration is undesirable since blood could be introduced into thesystem if aspiration continues after the balloon is deflated, the bumpseals the purge port 94. This is shown in FIGS. 15-16 , where the rightside represents the distal end of the balloon and the purge port spansbetween a distal section of the balloon and the distal tip of theballoon. In FIG. 15 , the balloon is inflated and bump 118 does notimpede the flow since the balloon is inflated and there is space for thefluid to pass. FIG. 16 shows the condition when the balloon is deflated,such as after the user has aspirated the balloon to deflate it. Bump 118now blocks the flow path, so once the balloon is completely deflated,further aspiration or suction is not possible.

In another embodiment, the purge port 94 seals itself when the balloonis fully inflated, to prevent any leakage from the balloon 18. In thisembodiment, the distal section of the purge port is integral with thedistal portion of the balloon wall. Thus, the balloon wall itselfcontains a lumen which defines the purge port. This may be made in anumber of ways, for example, the purge port may be first constructed andthen the balloon can be built over the purge port passage so that thepurge port is incorporate into the distal section of the balloon whenmaking the balloon, so that the distal portion of the balloon includesthe purge port incorporated into its wall. Alternately, the balloon canbe built and then a lumen can be introduced into the balloon, whereinthe lumen would define the purge port. The wall of the balloon willstretch and will thin as the balloon inflates. This stretching andthinning action will compress the purge port lumen, which isincorporated into the balloon wall, causing the purge port lumen toclose. Thus, when the balloon is fully inflated, the purge port willclose preventing any leakage.

Similar to the compressible purge port embodiment above which utilizedan elliptical, or C-shaped, or D-shaped cross sectional purge port shapeto aid the self-closing of the purge port, this embodiment may alsoutilize such a shape. A reinforcing band may also optionally be utilizedto create a choke point on the distal section of the balloon. Thisreinforcing band attaches to the balloon. As the balloon expands, theband applies force on the section of the purge port lumen directly underthe band since the distal purge port lumen is integrated into theballoon wall, which creates a choking point and closes the lumen. Thisembodiment may, optionally, also utilize the bump feature of FIGS. 15-16to create a system that would prevent balloon leakage when the balloonis inflated as well as prevent over-aspiration once the balloon isdeflated (via the bump mechanism). FIG. 17-18 shows the embodimentcontemplated here. Purge port 94 is shown, and is integral with theballoon 18 wall. In one example, the balloon 18 utilizes liners 120, 122which connect to part of the purge port. As the balloon 18 expands, theliners compress against the purge port 94 causing the purge port toclose (as shown in FIG. 17 , where the proximal section of purge port 94tapers down to the point it is completely shut). When the balloon isdeflated as shown in FIG. 18 , the purge port 94 opens and bump 118prevents over-aspiration, similar to the embodiment described earlier.Alternative configurations may solely utilize the band element or thenatural expansion of the balloon and the related decreasing wallthickness to close the purge port.

In another embodiment, the inner diameter of the outer assembly may betapered from the proximal to the distal end of the catheter, as shown inFIG. 10 . This taper will result in a tapered inflation lumen. Position98 indicated by the dashed line is similar to the distal end of theouter assembly indicated by position 98 in FIG. 2 . Inner assembly 16 isthe guidewire lumen of the earlier figures. In one example, the lumendiameter 20 a at position 98 is within the range of 0.02″-0.03″, and inin one more specific example 0.0293″. In one example, the lumen diameter20 b at the most proximal position of the balloon catheter is in therange of 0.03″-0.035″, in one more specific example 0.0305″.

The tapered lumen can be produced by utilizing a tapered mandrel to formouter assembly 14, said tapered mandrel would result in a tapered innerdiameter/lumen. The use of a taper means the proximal portion of theballoon catheter has a thinner structural layer and larger inflationvolume than the more distal portion of the balloon catheter, which has athicker structural layer and smaller inflation area. This difference ininflation volume is particularly beneficial for deflation of theballoon, where the higher proximal volume allows for greater suctionpressure than would be otherwise possible with a consistent volumetricprofile throughout lumen 20.

FIG. 11 illustrates another example of a tapered inflation lumen 21.Unlike the example in FIG. 10 , inflation lumen 21 utilizes a non-lineartaper that is curved from a larger diameter region 21B to a smallerdiameter region 21 a. Other shapes are also possible. Preferably, thetapered shape lacks sharp edges to prevent any areas where air can getcaught and create eddies or turbulence which would negatively affect thedeflation time. The inflation lumen shape can be formed by utilizing ashaped mandrel, and thus various shapes are contemplated by utilizing anappropriately shaped mandrel.

Similar to the earlier embodiments described, the tapered inner lumen 21can comprise a polymer with a higher melt temperature than outer layer14. The tapered inner lumen 21 can also include a metallic reinforcementlayer.

In another embodiment, a tapered inflation lumen is utilized, but thetaper is only utilized on a small portion of the lumen. Balloons andballoon catheters used in the neurovasculature typically have arelatively small size due to the smaller blood vessels in this region ofthe body. A taper is desirable in order to augment suction pressure,however, a continual taper is difficult to achieve given the limitedvolumetric capacity of the inflation lumen given the smaller size of thecatheter due to the smaller neurovasculature blood vessels. Thus, ataper may be used in a limited portion of the inflation lumen locatednear the balloon element. In one example the overall inflation lumenlength is 60-70 inches, and the taper exists in about 1-6 inches of theinflation lumen length. In one example, since the taper is limited to asmall section of the lumen instead of being distributed throughout thelumen, the transition from the smaller diameter to larger diametersection will be fairly significant.

In another embodiment, both the guidewire lumen 16 and inflation lumen20 utilize a taper. In one embodiment, the tapers utilized on bothlumens extend throughout a substantial length, respectively, or both theguidewire and inflation lumens. In another embodiment, the tapers arepresent through only a small portion, respectively, of each lumen (i.e.in about 1-6″ of overall length). In one example where both guidewirelumen 16 and inflation lumen 20 utilize a taper, the guidewire lumen 16has a distal section inner diameter (i.e. distal of the taper) of about0.01-0.015 inches, and a proximal section diameter (i.e. proximal of thetaper) of about 0.015 inches. The inflation lumen 20 has a distalsection inner diameter (i.e. distal of the taper) of about 0.023 inchesand a proximal section diameter (i.e. proximal to the taper) of about0.027 inches.

It is noted that while the present invention has been described withrespect to neurological procedures, it is contemplated that certainfeatures of the present balloon catheter also address needs innon-neurological fields.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A balloon catheter, comprising: a balloonattached to a distal portion of a tubular member, wherein the tubularmember includes an inflation lumen in communication with the balloon; apurge passage extending between an interior of the balloon and anexterior of the tubular member; and a first liner connected to the purgepassage; the purge passage having a first open configuration to allowmovement of fluid through the purge passage to the exterior of thetubular member and a second closed configuration to prevent movement offluid through the purge passage; and, wherein the first liner compressesthe purge passage when the purge passage is in the second closedconfiguration.
 2. The balloon catheter of claim 1, further comprising asecond liner connected to the purge passage, wherein the second linercompresses the purge passage when the purge passage is in the secondclosed configuration.
 3. The balloon catheter of claim 2, wherein thefirst liner is positioned on a first side of the purge passage, whereinthe second liner is positioned on a second side of the purge passage,and wherein the first side is opposite to the second side.
 4. Theballoon catheter of claim 2, wherein the first liner and the secondliner compress the purge passage without being exposed to fluid.
 5. Theballoon catheter of claim 1, wherein at least a portion of the purgepassage is sealed when in the second closed configuration.
 6. Theballoon catheter of claim 1, wherein an entire length of the purgepassage is sealed when in the second closed configuration.
 7. Theballoon catheter of claim 1, wherein the first liner compresses thepurge passage in response to an aspiration pressure.
 8. The ballooncatheter of claim 1, wherein the purge passage includes a restrictingmember which prevents over-aspiration.
 9. The balloon catheter of claim8, wherein the restricting member is comprised of a wall region havingan increased thickness.
 10. The balloon catheter of claim 8, wherein therestricting member is comprised of a projection.
 11. The ballooncatheter of claim 1, wherein the purge passage has an elliptical shapewhen in the first open configuration.
 12. A balloon catheter,comprising: a balloon attached to a distal portion of a tubular member,wherein the tubular member includes an inflation lumen in communicationwith the balloon; a purge passage extending between an interior of theballoon and an exterior of the tubular member; and a first linerconnected to a first side of the purge passage; a second liner connectedto a second side of the purge passage opposite to the first liner; thepurge passage having a first open configuration to allow movement offluid through the purge passage to the exterior of the tubular memberand a second closed configuration to prevent movement of fluid throughthe purge passage; and, wherein the first liner and the second linercompress the purge passage when the purge passage is in the secondclosed configuration, wherein at least a portion of the purge passage issealed when in the second closed configuration.
 13. The balloon catheterof claim 12, wherein the first liner and the second liner compress thepurge passage in response to a vacuum pressure.
 14. The balloon catheterof claim 12, wherein the first liner and the second liner compress thepurge passage without being exposed to fluid.
 15. The balloon catheterof claim 12, wherein the purge passage includes a restricting memberwhich blocks flow at a proximal end of the purge passage when theballoon is collapsed over the purge passage.
 16. The balloon catheter ofclaim 15, wherein the restricting member is positioned at a proximal endof the purge passage.
 17. The balloon catheter of claim 15, wherein therestricting member is comprised of a bump.
 18. The balloon catheter ofclaim 12, wherein the purge passage has a C- or D-shaped cross-sectionwhen in the first open configuration.
 19. The balloon catheter of claim12, further comprising a hydrophilic swellable material adjacent to thepurge passage.
 20. A balloon catheter, comprising: a balloon attached toa distal portion of a tubular member, wherein the tubular memberincludes an inflation lumen in communication with the balloon; a purgepassage extending between an interior of the balloon and an exterior ofthe tubular member, the purge passage having a first open configurationto allow movement of fluid through the purge passage to the exterior ofthe tubular member and a second closed configuration to prevent movementof fluid through the purge passage; and, a liner means for compressingthe purge passage when the purge passage is in the second closedconfiguration.